Trial Outcomes & Findings for A Comparison of Capnography Sampling Lines (NCT NCT03554629)

Last Updated: 2021-01-06

Results Overview

Comparison of measured end-tidal CO2 (EtCO2), Rebreathing as measured by fractional inspiratory CO2 (FiCO2) as a function the activity for 8 different CCSF designs tested on 23 subjects with supplemental O2 at 5lmp for four activities. Device data collected a 20Hz (20 data points/second) for the 3 hours of enrollment. Participants lateral lying with head on a pillow with supplemental O2 during each nasal only or open mouth breathing at respiration rate of 6 and 24.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Three hours

Results posted on

2021-01-06

Participant Flow

Execution of CIP v 1 enrollment at 6; data not included in results since data inadequate. Execution of CIP V2 enrollment was 23 One subject withdrawn before participation due to failure to meet failure to meet criteria of enrollment on the study day (runny nose)

Unit of analysis: Nasal/Oral-Nasal Sampling

Participant milestones

Participant milestones
Measure	Eight Capnography CO2 Sampling Filterline Performance Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities for data analysis. All subjects worn all 8 CCSF devices under test for the four study activities. 1 and 2. Closed mouth breathing with respiration rate of 6 and 24 3 and 4. Open mouth breathing with respiration rate at 6 and 24
Overall Study STARTED	29 232
Overall Study COMPLETED	23 184
Overall Study NOT COMPLETED	6 48

Reasons for withdrawal

Reasons for withdrawal
Measure	Eight Capnography CO2 Sampling Filterline Performance Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities for data analysis. All subjects worn all 8 CCSF devices under test for the four study activities. 1 and 2. Closed mouth breathing with respiration rate of 6 and 24 3 and 4. Open mouth breathing with respiration rate at 6 and 24
Overall Study Inadequate data	6

Baseline Characteristics

A Comparison of Capnography Sampling Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capnography CO2 Sampling Filterline n=23 Participants Capnography CO2 Sampling Filterline: Use of up to 8 Capnography CO2 Sampling FIlterlines by blinded code name during scripted activities
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants
Body Mass Index (BMI)	27.5 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants

PRIMARY outcome

Timeframe: Three hours

Population: Performance of 8 CO2 cannula sampling filterlines (CCSF): 4 filterlines provided nasal only sampling ports and 4 filterlines provided both nasal and oral sampling ports. Each of the 8 CCSF was assigned a letter by the investigation site to maintain blinding in data analysis. Side-stream capnography measurement via the Capnostream 35

Outcome measures

Outcome measures
Measure	EtCO2 During Mouth Closed Breathing Rate of 6 n=23 Participants Patient interface to sample gas for EtCO2 capnography measurement under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm.	FiCO2 During Mouth Closed Breathing Rate of 6 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm.	EtCO2 During Mouth Closed Breathing Rate of 24 n=23 Participants Patient interface to sample gas for end tidal CO2 (EtCO2)capnography measurement under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm.	FiCO2 During Mouth Closed Breathing Rate of 24 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm.	EtCO2 During Mouth Open Breathing Rate of 6 n=23 Participants Patient interface to sample gas for end tidal CO2 (EtCO2) capnography measurement under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm.	FiCO2 During Mouth Open Breathing Rate of 6 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm.	EtCO2 Mouth Open Breathing Rate of 24 n=23 Participants Patient interface to sample gas for capnography measurement under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm.	FiCO2 Mouth Open Breathing Rate of 24 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm.
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity FlexiCare (Nasal)	30.6 mmHg Standard Deviation 7.5	0.0 mmHg Standard Deviation 0.2	26.6 mmHg Standard Deviation 6.2	0.2 mmHg Standard Deviation 0.8	20.1 mmHg Standard Deviation 12.5	0.1 mmHg Standard Deviation 0.2	19.1 mmHg Standard Deviation 10.2	0.2 mmHg Standard Deviation 0.6
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity Hudson RCI /TeleFlex(Nasal)	13.5 mmHg Standard Deviation 8.4	0.0 mmHg Standard Deviation 0.0	12.3 mmHg Standard Deviation 6.9	0.0 mmHg Standard Deviation 0.1	7.6 mmHg Standard Deviation 6.6	0.0 mmHg Standard Deviation 0.0	7.8 mmHg Standard Deviation 7.2	0.0 mmHg Standard Deviation 0.0
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity Salter Lab (Nasal)	30.1 mmHg Standard Deviation 5.5	0.4 mmHg Standard Deviation 0.8	24.1 mmHg Standard Deviation 5.9	1.4 mmHg Standard Deviation 1.2	22.3 mmHg Standard Deviation 9.2	0.2 mmHg Standard Deviation 0.3	19.9 mmHg Standard Deviation 7.6	1.0 mmHg Standard Deviation 1.1
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity Medtronic Filterline (Nasal)	32.6 mmHg Standard Deviation 5.4	0.0 mmHg Standard Deviation 0.0	28.1 mmHg Standard Deviation 5.2	0.0 mmHg Standard Deviation 0.2	24.8 mmHg Standard Deviation 8.3	0.0 mmHg Standard Deviation 0.0	22.7 mmHg Standard Deviation 7.6	0.0 mmHg Standard Deviation 0.0
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity WestMed (Oral/Nasal)	33.9 mmHg Standard Deviation 4.8	0.5 mmHg Standard Deviation 0.4	29.2 mmHg Standard Deviation 5.8	1.4 mmHg Standard Deviation 1.5	28.0 mmHg Standard Deviation 8.9	0.5 mmHg Standard Deviation 0.6	24.1 mmHg Standard Deviation 8.1	1.2 mmHg Standard Deviation 1.4
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity Dispo-Med (Oral/Nasal)	29.9 mmHg Standard Deviation 7.5	0.1 mmHg Standard Deviation 0.3	23.8 mmHg Standard Deviation 8.2	1.4 mmHg Standard Deviation 0.9	23.6 mmHg Standard Deviation 6.9	0.1 mmHg Standard Deviation 0.2	19.3 mmHg Standard Deviation 7.0	1.4 mmHg Standard Deviation 1.3
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity Salter Lab Oral-Trac (Oral/Nasal)	29.3 mmHg Standard Deviation 8.7	0.3 mmHg Standard Deviation 0.5	25.0 mmHg Standard Deviation 6.9	0.6 mmHg Standard Deviation 0.9	26.8 mmHg Standard Deviation 5.2	0.2 mmHg Standard Deviation 0.3	23.4 mmHg Standard Deviation 4.7	0.9 mmHg Standard Deviation 1.1
Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity Medtronic Smart Capnoline+(Oral/Nasal)	32.6 mmHg Standard Deviation 5.4	0.0 mmHg Standard Deviation 0.0	28.8 mmHg Standard Deviation 4.8	0.0 mmHg Standard Deviation 0.1	26.8 mmHg Standard Deviation 7.4	0.0 mmHg Standard Deviation 0.0	24.9 mmHg Standard Deviation 6.2	0.0 mmHg Standard Deviation 0.1

SECONDARY outcome

Timeframe: Three hours

Population: Participant actual Respiration Rate was coached using the Pace Breathing Android App: Version 2.1. RR = 6 : Inspiratory Time was 5.0 seconds and Expiratory time was 5.0 seconds No breath alarm is deployed when both RR and EtCO2 are equal to zero. RR = 24: Inspiratory Time was 1.2 seconds and Expiratory time was 1.3 seconds

Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time. The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform.

Outcome measures

Outcome measures
Measure	EtCO2 During Mouth Closed Breathing Rate of 6 n=23 Participants Patient interface to sample gas for EtCO2 capnography measurement under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm.	FiCO2 During Mouth Closed Breathing Rate of 6 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm.	EtCO2 During Mouth Closed Breathing Rate of 24 n=23 Participants Patient interface to sample gas for end tidal CO2 (EtCO2)capnography measurement under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm.	FiCO2 During Mouth Closed Breathing Rate of 24 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm.	EtCO2 During Mouth Open Breathing Rate of 6 n=23 Participants Patient interface to sample gas for end tidal CO2 (EtCO2) capnography measurement under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm.	FiCO2 During Mouth Open Breathing Rate of 6 n=23 Participants Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm.	EtCO2 Mouth Open Breathing Rate of 24 Patient interface to sample gas for capnography measurement under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm.	FiCO2 Mouth Open Breathing Rate of 24 Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm.
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 FlexiCare (Nasal)	0.17 Alarms Standard Deviation 0.53	0.13 Alarms Standard Deviation 0.40	0.35 Alarms Standard Deviation 0.57	0.30 Alarms Standard Deviation 0.51	0.17 Alarms Standard Deviation 0.38	0.15 Alarms Standard Deviation 0.36	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 Hudson/TeleFlex (Nasal)	0.20 Alarms Standard Deviation 0.40	0.13 Alarms Standard Deviation 0.34	0.74 Alarms Standard Deviation 0.53	0.63 Alarms Standard Deviation 0.57	0.52 Alarms Standard Deviation 0.51	0.50 Alarms Standard Deviation 0.51	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 Salter Labs (Nasal)	0.02 Alarms Standard Deviation 0.15	0.02 Alarms Standard Deviation 0.15	0.37 Alarms Standard Deviation 0.61	0.22 Alarms Standard Deviation 0.47	0.13 Alarms Standard Deviation 0.34	0.04 Alarms Standard Deviation 0.21	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 Medtronic CO2 (Nasal)	0.02 Alarms Standard Deviation 0.15	0.02 Alarms Standard Deviation 0.15	0.17 Alarms Standard Deviation 0.38	0.11 Alarms Standard Deviation 0.31	0.13 Alarms Standard Deviation 0.40	0.07 Alarms Standard Deviation 0.25	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 WestMed (Oral/Nasal)	0.04 Alarms Standard Deviation 0.29	0.04 Alarms Standard Deviation 0.29	0.13 Alarms Standard Deviation 0.34	0.11 Alarms Standard Deviation 0.31	0.09 Alarms Standard Deviation 0.28	0.09 Alarms Standard Deviation 0.28	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 DispoMed (Oral/Nasal)	0.04 Alarms Standard Deviation 0.21	0.04 Alarms Standard Deviation 0.21	0.37 Alarms Standard Deviation 0.53	0.28 Alarms Standard Deviation 0.46	0.20 Alarms Standard Deviation 0.45	0.15 Alarms Standard Deviation 0.36	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 Salter Oral-Trac (Oral/Nasal)	0.02 Alarms Standard Deviation 0.15	0.02 Alarms Standard Deviation 0.15	0.22 Alarms Standard Deviation 0.47	0.11 Alarms Standard Deviation 0.31	0.13 Alarms Standard Deviation 0.40	0.07 Alarms Standard Deviation 0.25	—	—
Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 Medtronic Smart CapnoLine Plus (Oral/Nasal)	0.00 Alarms Standard Deviation 0.00	0.00 Alarms Standard Deviation 0.00	0.09 Alarms Standard Deviation 0.28	0.09 Alarms Standard Deviation 0.28	0.04 Alarms Standard Deviation 0.21	0.04 Alarms Standard Deviation 0.21	—	—

SECONDARY outcome

Timeframe: Three hours